Contract Diagnostics’ Post

MHRA, FDA, and Health Canada have collaborated to set guiding principles on transparency for machine-learning medical devices. These principles, in alignment with previous guidelines, provide essential transparency practices for all medical devices. Stay informed on these crucial standards: Published: 13 June 2024 #MHRA #FDA #HealthCanada #MedicalDevices #Medtech #AI #machinelearning

MHRA launches regulatory sandbox for AI medical devices - Digital Health #MHRA Regulatory Sandbox for AI Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox for AI medical devices to streamline the approval process and ensure patient safety. #MHRARegulatorySandbox #AI Airlock for Medical Devices The regulatory sandbox, known as the AI Airlock, will provide a safe space for developers to test and validate their AI medical devices before seeking regulatory approval. #AIAirlock #Benefits of the Regulatory Sandbox By participating in the regulatory sandbox, developers can receive guidance from the MHRA on regulatory requirements, expedite the approval process, and ultimately bring their AI medical devices to market faster. #BenefitsOfSandbox #How to Apply Developers ai.mediformatica.com #mhra #health #devices #themhra #healthcare #medical #medicaldevice #medicaldevices #regulatorysandbox #alamd #digital #aiasamedicaldevice #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3K7ismV)

Practical, consensus guidance on how to get the best out of technology in healthcare is always welcome. User buy-in is critical for all devices, no matter how sophisticated, to be accepted and scaled to where they can help the most patients.

Brilliant insights! Navigating the medical device development process is no small feat, but with a solid strategy and the right expertise, success is within reach. These article is a knowledge pill about how to make a medical device development successful, so I encourage you to read it. 🧐

🚨🚨 Regulatory Update for Medical Devices 🚨🚨 Several significant updates have emerged in the regulatory landscape for medical devices. Here are the key highlights: 1. MDCG Guidance on Standardisation for Medical Devices: The European Commission has released the MDCG 2021-5 Rev.1 guidance on standardisation for medical devices as of July 2024. This update aims to assist stakeholders in implementing the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) by providing clearer guidelines on standardisation processes. 2. EU Classification Rules for IVDs: A new version of the MDCG 2020-16 guidance has been issued, focusing on the classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746. This July 2024 update provides detailed insights into the classification criteria and helps manufacturers better understand their regulatory obligations. 3. Singapore’s HSA Fee Increase: Starting July 1, 2024, Singapore’s Health Sciences Authority (HSA) has increased the registration fees for all medical device registration routes. This change reflects the HSA's ongoing efforts to streamline regulatory processes and ensure adequate resources for thorough reviews. 4. Australia’s TGA Updates: The Therapeutic Goods Administration (TGA) in Australia has emphasized the importance of distribution record-keeping for medical devices. This update, effective from May 23, 2024, highlights the need for manufacturers and distributors to maintain comprehensive records to ensure traceability and compliance. 5. EU AI Act and High-Risk AI Systems: The European Artificial Intelligence Act (AIA) is nearing finalization, with new requirements focusing on high-risk AI systems, including those used in medical devices. This legislation aims to ensure the safe and ethical use of AI in healthcare, emphasizing transparency and accountability. Conclusion: Keeping abreast of these updates is crucial for regulatory affairs professionals to ensure compliance and maintain the safety and efficacy of medical devices. As the regulatory environment continues to evolve, adapting to the latest standards and guidelines is essential. Stay tuned for more updates and insights on the ever-changing regulatory landscape. #MedicalDevices #RegulatoryAffairs #MDR #IVDR #HSA #TGA #ArtificialIntelligence #Compliance #Healthcare #MedicalDeviceIndustry #Innovation #QualityControl

𝐌𝐨𝐬𝐭 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐬𝐭𝐚𝐫𝐭𝐮𝐩𝐬 𝐧𝐞𝐯𝐞𝐫 𝐫𝐞𝐚𝐜𝐡 𝐭𝐡𝐞 𝐦𝐚𝐫𝐤𝐞𝐭. 𝐖𝐡𝐲? Successfully launching a new medical device requires more than effective marketing or distribution strategies. Medical Device Regulation (EU) 2017/745 places great emphasis on quality, safety and performance of each product, regardless of its complexity. Finally, future manufacturers may need to decide whether the product should comply with MDR or medicinal product Directive 2001/83/EC (MPD) (you can learn more about this in our blog article): ➡ https://lnkd.in/dwkTEDvc   Therefore, anyone who plans to introduce the medical device to the market must be aware of the many stages that are necessary to go through, or at least consider:   ·       💡 Idea (preferably unique!) and Risk Analysis ⚠ ·       📐 Medical Device Conceptualization and Regulatory Compliance ·       🛠 Design and Development ·       🧪Pre-clinical Testing ·       🩺Clinical Trails ·       ✅Regulatory Approval, and finally ·       🚀Market Launch and Post-Market Activities.   It is a demanding journey requiring multidisciplinary team, only for the truly patient and persistent ones. The whole process can be time-consuming with potential delays or failures in launch. 🕰️ Did you know that there are ways to 𝐢𝐧𝐜𝐫𝐞𝐚𝐬𝐞 𝐲𝐨𝐮𝐫 𝐜𝐡𝐚𝐧𝐜𝐞𝐬 of successfully introducing a medical device to the market❓ This can be achieved for example, by: ✅  Thorough market analysis ✅  User-focused planning and design ✅  Proper risk analysis ✅  Compliance with regulatory requirements ✅  Multidisciplinary approach ✅ External experts and consultants help Fortunately, you don't have to navigate this intricate process alone! At #SciencePharma, we are ready to guide you through all stages of medical device development: from idea to market access. If you have any questions or need assistance, please feel free to contact us! 📞✉️ #medicaldevice #marketlaunch #regulatoryapproval #medicaldeviceregulation #MedTech

Delighted to share the latest from the MHRA's Med Tech Regulatory Reform blog series, an insightful reflection on the progress and initiatives shaping the future of medical device regulation in the UK. As we celebrate British Science Week and International Women’s Day, it's inspiring to see the leadership and contributions of talented female scientists in driving these advancements. This March has been eventful with significant milestones including the announcement of eight innovative devices entering the Access Pathway pilot, the passing of the IVDR for NI, and the successful hosting of a webinar attended by 1,400 participants discussing the essential aspects of upcoming regulations. The MHRA's commitment to clarity, safety, and international alignment in medical device regulation is commendable. Their approach, especially in defining Software as a Medical Device and adjusting classifications to align with international standards, indicates a forward-thinking and inclusive regulatory framework. Moreover, the engagement through webinars and Trusted Advisor Principles highlights an effective strategy for inclusive policy development and stakeholder engagement. As we look forward to the international discussions at the IMDRF meeting, it's clear the UK is poised to make a significant impact on the global stage, with the ambition of setting a regulatory framework others can trust and potentially recognise. These efforts underscore the importance of collaborative, transparent, and adaptive regulation in ensuring patient safety and supporting innovation in the medtech sector. Eager to see how these developments unfold and impact both the UK and global medical device landscapes. For comprehensive support on navigating your medical device regulatory compliance pathway, visit us at www.deviceology.net Our expertise and insights could be the catalyst your innovations need to thrive in regulated markets.

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway - npj Digital Medicine #BeyondThe510k: Regulation of Moderate-Risk Medical Devices, Intellectual Property, and Innovation Incentives in FDA's De Novo Pathway #Introduction The blog post explores the regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway. This pathway is an alternative to the 510(k) process for medical devices that do not have a legally marketed predicate device. #Understanding the De Novo Pathway The De Novo pathway allows for the classification of moderate-risk medical devices that have no predicate device. It provides a regulatory framework for evaluating the safety and effectiveness of such devices. #Benefits of the De Novo Pathway The De Novo pathway offers several benefits ai.mediformatica.com #medical #devices #market #digital #medicaldevices #this #software #innovation #regulation #risk #medicine #technology #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3UF3Hyh)

❓How can manufacturers ensure well-researched clinical investigations and a return on investment? ❓What types of clinical investigations can be conducted for medical devices? ❓How much clinical data is enough for medical devices? Do you have questions about clinical investigations? Our experts have compiled the most common questions (aka frustrations) manufacturers face, providing clear answers. No more searching through countless documents or forums. Find concise and accurate information here, saving you time and reducing frustration. ✅https://lnkd.in/egk2ScW6 #medicaldevice #clinicaldata #returnoninvestment #mdr #clinicalinvestigation #technicaldocumentation #regulatoryaffairs #medtech #clinicalevaluation #medicaldeviceregulation #regulatorycompliance #euregulation